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临床试验/NCT04828083
NCT04828083
已完成
4 期

The Efficacy of Systemic Lidocaine Versus Ultrasound-guided Adductor Canal Block for Patients Undergoing Total Knee Arthroplasty: a Randomized, Double-blinded, Non-inferiority Study

Rhode Island Hospital1 个研究点 分布在 1 个国家目标入组 120 人2021年3月1日

概览

阶段
4 期
干预措施
Saline IV
疾病 / 适应症
Arthroplasty, Replacement, Knee
发起方
Rhode Island Hospital
入组人数
120
试验地点
1
主要终点
Postoperative opioid consumption
状态
已完成
最后更新
上个月

概览

简要总结

The investigators are evaluating the postoperative outcomes in patients undergoing total knee arthroplasty that receive either systemic lidocaine or ultrasound-guided adductor canal block as part of their anesthetic plan.

详细描述

Patients scheduled to have total knee arthroplasty will typically receive a single shot adductor canal block to serve as the primary anesthetic and as part of a multi-modal post-operative analgesic plan. The use of adductor canal block is still limited to where trained anesthesiologists in regional anesthesia are available. There are other nonopioid analgesic adjuncts, such as Lidocaine, which is is widely available and is a very commonly used local anesthetic. A major advantage of lidocaine is that it is not associated with a significant side effect profile. Intravenous lidocaine which can be administered during surgery and/or after surgery has demonstrated anti-inflammatory effects and can significantly decrease the reliance on opioid use for adequate pain management in abdominal and spine surgeries. The addition of systemic lidocaine infusion as part of a multimodal analgesia strategy to minimize opioid related side effects might prove to be a useful combination for clinicians where adductor canal blocks are not a viable option. However, the level of evidence comparing the efficacy of intravenous lidocaine versus adductor canal block to reduce postoperative opioid consumption in patients undergoing TKA is limited. We hypothesized that there will be no meaningful clinical difference between systemic lidocaine and ultrasound-guided adductor canal block in the 24-hour postoperative analgesia period.

注册库
clinicaltrials.gov
开始日期
2021年3月1日
结束日期
2024年9月2日
最后更新
上个月
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

责任方
Sponsor

入排标准

入选标准

  • ASA PS 1-3 patients undergoing primary, unilateral total knee arthroplasty

排除标准

  • ASA PS classification of 4 or greater
  • Pre-existing neuropathy
  • Coagulopathy
  • Chronic opioid consumption (\>3 months)
  • Infection at the site
  • Known allergy to study medications (lidocaine)
  • High grade atrioventricular block (cardiac conduction system impairment)
  • A history of CVA/TIA
  • Currently using lidocaine patches
  • Known liver disease

研究组 & 干预措施

Ultrasound-guided adductor canal block with local anesthetic

Single shot Ultrasound-guided adductor canal block with 0.5% ropivacaine 30 ml

干预措施: Saline IV

Ultrasound-guided adductor canal block with saline

Single shot Ultrasound-guided adductor canal block with 30 mL of normal saline (Sodium chloride)

干预措施: Lidocaine IV

结局指标

主要结局

Postoperative opioid consumption

时间窗: 24 hours

Postoperative opioid consumption will be converted to equivalent dose of oral morphine.

次要结局

  • Pain Scores(up to 2 hours (post anesthesia recovery unit), 6 hours, 12 hours, and 24 hours after surgery.)
  • Quality of Recovery(24 hours)

研究点 (1)

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